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PET Imaging in Cocaine Self Administration

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[11C]-P943
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cocaine Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age 18 - 50 years
  2. voluntary, written, informed consent
  3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
  4. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (B-HCG) test
  5. English speaking
  6. No other major Axis DSM-IV diagnosis present, besides required as below

Inclusion criteria for cocaine dependent:

  1. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
  2. recent street cocaine use
  3. intravenous and/or smoked (crack/ freebase) use
  4. positive urine toxicology screen for cocaine

Inclusion criteria for healthy controls:

  1. No current, or history of, any DSM-IV diagnosis
  2. No first-degree relative with history of psychotic, mood, or anxiety disorder

Exclusion Criteria:

  1. medical contraindications to AMPT administration (e.g., known sensitivity/reaction to AMPT)
  2. medical contraindications to MPH administration (e.g., history of cardiac problems, seizures, etc.)
  3. drug or alcohol dependence (except nicotine)
  4. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine or pathological gambling
  5. positive answers on the cardiac screening questionnaire that may place the subject at higher risk, as determined by cardiologist review of both the questionnaire responses and screening ECG
  6. current use of psychotropic and/or potentially psychoactive prescription medication
  7. physical or laboratory (B-HCG) evidence of pregnancy
  8. clotting disorders or recent anticoagulant therapy
  9. MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker)
  10. history of claustrophobia or feeling of inability to lie still on his back for the PET or MRI scans
  11. history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over Radioactive Drug Research Committee (RDRC) limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
  12. donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug
  13. use any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements within 2 weeks prior to study and for the duration of the study without approval from the study doctor
  14. eat grapefruit or grapefruit products, and drink alcohol, and anything containing caffeine 3 days before study and during study
  15. For CD subjects, < 1 year of cocaine dependence
  16. Subjects with current, past, or anticipated exposure to radiation in the workplace

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

P943 PET Scan

Arm Description

Outcomes

Primary Outcome Measures

BPND
BPND is a measure of serotonin receptor availability

Secondary Outcome Measures

Full Information

First Posted
July 1, 2014
Last Updated
November 18, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02181491
Brief Title
PET Imaging in Cocaine Self Administration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There has been recent interest in the role of the 5-HT1B receptor as a possible modulating factor in cocaine dependence, certainly in preclinical models. The Yale Positron Emission Tomography (PET) Center has developed a novel 5-HT1B receptor antagonist radioligand, [11C]-P943, which has been validated in human studies. We hypothesize that the 5-HT1B receptor plays a key role in cocaine dependence. The long term goal of this project would be to study pharmacological manipulation of the 5-HT1B receptor as a potential molecular target for cocaine dependence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P943 PET Scan
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
[11C]-P943
Primary Outcome Measure Information:
Title
BPND
Description
BPND is a measure of serotonin receptor availability
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18 - 50 years voluntary, written, informed consent physically healthy by medical history, physical, neurological, ECG, and laboratory examinations for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (B-HCG) test English speaking No other major Axis DSM-IV diagnosis present, besides required as below Inclusion criteria for cocaine dependent: DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20) recent street cocaine use intravenous and/or smoked (crack/ freebase) use positive urine toxicology screen for cocaine Inclusion criteria for healthy controls: No current, or history of, any DSM-IV diagnosis No first-degree relative with history of psychotic, mood, or anxiety disorder Exclusion Criteria: medical contraindications to AMPT administration (e.g., known sensitivity/reaction to AMPT) medical contraindications to MPH administration (e.g., history of cardiac problems, seizures, etc.) drug or alcohol dependence (except nicotine) a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine or pathological gambling positive answers on the cardiac screening questionnaire that may place the subject at higher risk, as determined by cardiologist review of both the questionnaire responses and screening ECG current use of psychotropic and/or potentially psychoactive prescription medication physical or laboratory (B-HCG) evidence of pregnancy clotting disorders or recent anticoagulant therapy MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker) history of claustrophobia or feeling of inability to lie still on his back for the PET or MRI scans history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over Radioactive Drug Research Committee (RDRC) limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug use any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements within 2 weeks prior to study and for the duration of the study without approval from the study doctor eat grapefruit or grapefruit products, and drink alcohol, and anything containing caffeine 3 days before study and during study For CD subjects, < 1 year of cocaine dependence Subjects with current, past, or anticipated exposure to radiation in the workplace
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Potenza, PhD, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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PET Imaging in Cocaine Self Administration

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